Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers: rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial

TY - JOUR

T1 - Clinical effectiveness and cost-effectiveness of the rehabilitation enablement in chronic heart failure facilitated self-care rehabilitation intervention for people with heart failure with preserved ejection fraction and their caregivers

T2 - rationale and protocol for a multicentre randomised controlled trial – REACH-HFpEF trial

AU - Taylor, Rod S.

AU - Burrell, Emma

AU - O’Hare, Claire

AU - Thomson, Elizabeth A.

AU - Placzek, Anna

AU - Bollen, Jessica C

AU - Cleland, John G F

AU - Cowie, Ansley

AU - Dalal, Hasnain M

AU - Deaton, Christi

AU - Doherty, Patrick

AU - Dudman, Katie

AU - Fraser, Heather

AU - Frost, Julia

AU - Greaves, Colin J

AU - Hartshorne-Evans, Nick

AU - Hillsdon, Melvyn

AU - Ibbotson, Tracy

AU - Jarallah, Mohammad

AU - Jolly, Kate

AU - McConnachie, Alex

AU - McIntosh, Emma

AU - Smith, Valerie

AU - Squire, Iain

AU - Taylor, Louise

AU - van Beurden, Samantha

AU - Lang, Chim C

AU - REACH-HFpEF Investigators

N1 - © Author(s) (or their employer(s)) 2025.

PY - 2025/5/27

Y1 - 2025/5/27

N2 - Introduction Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers. Methods and analysis REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients' disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators' experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked. Ethics and dissemination The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers. Trial registration number ISRCTN47894539.

AB - Introduction Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers. Methods and analysis REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients' disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators' experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked. Ethics and dissemination The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers. Trial registration number ISRCTN47894539.

KW - Heart Failure

KW - Preserved Ejection Fraction

KW - Rehabilitation

KW - Self-care

KW - Diastolic dysfunction

U2 - 10.1136/bmjopen-2024-094254

DO - 10.1136/bmjopen-2024-094254

M3 - Article

C2 - 40436450

SN - 2044-6055

VL - 15

JO - BMJ Open

JF - BMJ Open

IS - 5

M1 - e094254

ER -